NCT07044830

Brief Summary

The study aims to evaluate whether early treatment of obstructive sleep apnea with continuous positive airway pressure in ischemic stroke patients has a favorable effect on functional recovery.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
425

participants targeted

Target at P75+ for not_applicable

Timeline
58mo left

Started Feb 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
Feb 2024Feb 2031

Study Start

First participant enrolled

February 28, 2024

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 1, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 1, 2025

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2029

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2031

Last Updated

July 1, 2025

Status Verified

March 1, 2025

Enrollment Period

5 years

First QC Date

June 1, 2025

Last Update Submit

June 21, 2025

Conditions

Ischemic StrokeObstructive Sleep Apnea

Keywords

StrokeObstructive Sleep ApneaSleep

Outcome Measures

Primary Outcomes (1)

  • Functional disability

    Measured by the modified Rankin Scale, ranging from 0 (no symptoms) to 6 (death), with higher scores indicating greater disability and dependence on daily activities.

    3 months

Secondary Outcomes (7)

  • Neurological impairment

    Admission, 72 hours, day 5/discharge, 3 months, and 6 months

  • Functional independence

    Day 5/discharge, 3 months, 6 months, 1 year, and 2 years

  • Cognitive impairment

    Day 5/discharge, 3 months, 1 year, and 2 years

  • Subjective quality of life

    Day 5/discharge, 3 months, 6 months, 1 year, and 2 years

  • Depressive episode

    Day 5/discharge, 3 months, 1 year, and 2 years

  • +2 more secondary outcomes

Study Arms (5)

Severe OSA treated

ACTIVE COMPARATOR

AHI≥30: treated with CPAP

Device: CPAP

Severe OSA untreated

NO INTERVENTION

AHI≥30: without CPAP

No OSA

NO INTERVENTION

AHI\<5

Mild OSA

NO INTERVENTION

5≥AHI\<15

Moderate OSA

NO INTERVENTION

15≤AHI\<30

Interventions

CPAPDEVICE

Automatically-adjusting continuous positive airway pressure (CPAP)

Severe OSA treated

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Supratentorial non-lacunar ischemic stroke, including anterior, middle, and posterior cerebral artery territories
  • Aged 18 to 80 years
  • Symptom onset or symptom recognition to admission \< 12 hours
  • NIHSS score ≥ 4 and ≤ 20 at enrollment
  • Signed informed consent form obtained from the participant or their legal representative

You may not qualify if:

  • Prior stroke
  • Previous diagnosis of OSA with current CPAP use or previously failed CPAP
  • Pre-stroke disability (mRS \> 1)
  • Coma or stupor
  • Orotracheal intubation
  • Clinical instability or severe pre-existing illness (e.g., heart failure, oxygen-dependent COPD, renal or hepatic failure)
  • Psychomotor agitation
  • High likelihood of neurosurgical intervention within the first 48 hours
  • Oxygen therapy \>2 L/min
  • Known severe neurological disease (e.g., dementia, Parkinson's disease, multiple sclerosis, or other neurodegenerative conditions)
  • Chronic alcohol or drug use with high risk of withdrawal during hospitalization
  • Pregnant or suspected pregnant women
  • Inability to complete follow-up for any reason
  • Any contraindication to CPAP use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital das Clínicas, Ribeirão Preto Medical School, University of São Paulo

Ribeirão Preto, São Paulo, 14015-130, Brazil

RECRUITING

MeSH Terms

Conditions

Ischemic StrokeSleep Apnea, ObstructiveStroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake Disorders

Central Study Contacts

Millene Camilo, MD, PhD

CONTACT

+55-16-36059075millene.camilo@fmrp.usp.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 1, 2025

First Posted

July 1, 2025

Study Start

February 28, 2024

Primary Completion (Estimated)

February 28, 2029

Study Completion (Estimated)

February 28, 2031

Last Updated

July 1, 2025

Record last verified: 2025-03

Locations

BR(1)